Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia

Phase 3

Completed

Conditions: Supraventricular Tachycardia
AtrioVentricular Nodal Reentrant Tachycardia
Heart Disease

Interventions: Device: Freezor Xtra Cryoablation Catheter

Registration Number: NCT01426425

Lead Sponsor: Medtronic Cardiac Ablation Solutions

Brief Summary: ICY-AVNRT (Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia) is a prospective multi-center, nonrandomized, single arm, controlled, unblinded, investigational clinical study. The purpose of this clinical study is to demonstrate the safety and effectiveness of the Freezor® Xtra Cardiac CryoAblation Catheter for the cryoablation of the conducting tissues of the heart in the treatment of patients with atrioventricular nodal reentrant tachycardia (AVNRT) using an endocardial approach.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 572

Inclusion Criteria

Supraventricular tachycardia (SVT) compatible with atrioventricular nodal reentrant tachycardia (AVNRT), documented by ECG, TTM, Holter or event monitor

Pre-Electrophysiology Study

Exclusion Criteria

History of sustained (≥30 seconds) of ventricular tachycardia
Atrial tachycardia or other arrhythmia that could be confused with AVNRT
Reversible cause of SVT
History of previous AVNRT ablation
Therapy with amiodarone within last 90 days
Unstable angina/myocardial infarction/open heart surgery in past 60 days
New York Heart Association (NYHA) Classification III or IV currently or within the past 90 days
Implantable cardiac rhythm device
Atrioventricular block (first degree (PR interval ≥ 220ms), second degree, or third degree) or left bundle branch block
Stroke or transient ischemic attack within the past 180 days
Life expectancy less than 12 months
Female known to be pregnant
Unable/unwilling to give informed consent
Unable/unwilling to comply with follow-up visits and study requirements
Less than 18 years of age
Active systemic infection
Cryoglobulinemia
Other conditions where the manipulation of the catheter would be unsafe (for example, intracardiac mural thrombus)
Participating in a concurrent clinical study that may confound the results of this study

Post-Electrophysiology Study Inclusion Criteria:

Subject must have one electrophysiology study documented inducible sustained (greater than or equal to 15 seconds) supraventricular tachycardia that is classified as AVNRT.

Post-Electrophysiology Study Exclusion Criteria:

Presence of a second inducible arrhythmia that could be confused with AVNRT during follow-up or will likely result in ablation within the next 6 months
Presence of inducible sustained ventricular tachycardia or fibrillation
Presence of an accessory pathway
Presence of abnormal conduction or refractoriness parameters of the atrioventricular conduction system.
Indication for a pacemaker, defibrillator or cardiac resynchronization therapy (CRT)

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cryoablation	Freezor Xtra Cryoablation Catheter	Subjects diagnosed with atrioventricular nodal reentrant tachycardia and treated by cryoablation with Freezor Xtra.

Primary Outcome Measures

Name	Time	Method
Chronic Safety (Through 6 Months) of the Freezor Xtra Catheter When Used for the Treatment of AVNRT Using an Endocardial Approach.	6 Months	Subjects who had at least one safety event during or after their cryoablation procedure or through 6 months of follow-up are considered a primary (chronic) safety failure. A safety event is defined as the occurrence of any adverse event that is adjudicated by the AE Adjudication Committee as being serious and study ablation procedure-related and/or Freezor Xtra Catheter related that: 1) Resulted in death, 2) Resulted in a life-threatening illness or injury, 3) Resulted in permanent impairment of a body function or permanent damage to a body structure, 4) Necessitated significant intervention, such as major surgery or even intravenous medical therapy (e.g., vasopressors), to prevent permanent impairment of a body function or permanent damage to a body structure, or 5) Required in-patient hospitalization or a prolongation of an existing hospital stay.
Chronic Effectiveness (Through 6 Months) of the Freezor Xtra Catheter for the Treatment of AVNRT Using an Endocardial Approach.	6 months	Subjects must have met both of the following acute and chronic conditions to be considered a chronic effectiveness (treatment) success: * Acute Success: The inability to induce more than one echo beat by the same pacing maneuvers that induced AVNRT before cryoablation (with drug provocation if required for induction before cryoablation) at the conclusion of the study cryoablation procedure assessment. * Chronic Success: Lack of documented recurrence of clinical AVNRT during the 6-month follow-up period after the study cryoablation procedure.

Secondary Outcome Measures

Name	Time	Method
Chronic Effectiveness (Through 6 Months) of the Freezor Xtra Catheter for the Treatment of AVNRT in Subjects Who Achieved Acute Procedural Success.	6 Months	If there was no documented evidence of AVNRT recurrence in the post-procedure 6-month follow-up period, the subject is counted as a chronic effectiveness success. The AE Adjudication Committee adjudication of AVNRT recurrence is used to classify subjects for this endpoint.

Trial Locations

Locations (34): Montreal Heart Institute
🇨🇦
Montreal, Quebec, Canada
Baylor Heart and Vascular Hospital
🇺🇸
Dallas, Texas, United States
University of Rochester Medical Center
🇺🇸
Rochester, New York, United States
Banner Good Samaritan Medical Center
🇺🇸
Phoenix, Arizona, United States
Baptist Hospital of Miami
🇺🇸
Miami, Florida, United States
University of Michigan Medical Center
🇺🇸
Ann Arbor, Michigan, United States
Stanford Hospital and Clinics
🇺🇸
Stanford, California, United States
Piedmont Heart Institute
🇺🇸
Atlanta, Georgia, United States
Advocate Christ Medical Center
🇺🇸
Oak Lawn, Illinois, United States
Park Nicollet Institute
🇺🇸
Saint Louis Park, Minnesota, United States
Southside Hospital
🇺🇸
Bay Shore, New York, United States
Healtheast St. Joseph's Hospital
🇺🇸
Saint Paul, Minnesota, United States
Sacred Heart Medical Center
🇺🇸
Springfield, Oregon, United States
Cleveland Clinic
🇺🇸
Cleveland, Ohio, United States
Sanger Heart and Vascular Institute
🇺🇸
Charlotte, North Carolina, United States
Miami Valley Cardiologists
🇺🇸
Dayton, Ohio, United States
Geisinger Medical Center
🇺🇸
Danville, Pennsylvania, United States
Capital Cardiovascular Associates
🇺🇸
Camp Hill, Pennsylvania, United States
Wellmont Cardiovascular Heart Institute
🇺🇸
Kingsport, Tennessee, United States
St. Luke's Episcopal
🇺🇸
Houston, Texas, United States
Virginia Heart
🇺🇸
Falls Church, Virginia, United States
London Health Sciences Centre
🇨🇦
London, Ontario, Canada
Victoria Cardiac Arrhythmia Trials, Inc.
🇨🇦
Victoria, British Columbia, Canada
McGill University Health Centre
🇨🇦
Montreal, Quebec, Canada
Hopital du Sacre Coeur de Montreal
🇨🇦
Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Sherbrooke
🇨🇦
Sherbrooke, Quebec, Canada
Prairie CardioVascular Research Network
🇨🇦
Regina, Saskatchewan, Canada
Geisinger Wyoming Valley Medical Center
🇺🇸
Wilkes-Barre, Pennsylvania, United States
Pacific Heart Institute
🇺🇸
Santa Monica, California, United States
Baylor Research Institute
🇺🇸
Plano, Texas, United States
Orlando Regional Medical Center
🇺🇸
Orlando, Florida, United States
Iowa Heart Center
🇺🇸
Des Moines, Iowa, United States
Royal Alexandra Hospital
🇨🇦
Edmonton, Alberta, Canada
Montefiore Medical Center
🇺🇸
Bronx, New York, United States